FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENDO-LASE CD-100 CO2 LASER FOR NEUROSURGERY
K Number: K853878
·
Decision May 2, 1986
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
24
Review Days
227
Basic Information
- Device Name
- ENDO-LASE CD-100 CO2 LASER FOR NEUROSURGERY
- K Number
- K853878
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- ENDO LASE, INC.
- Date Received
- September 17, 1985
- Decision Date
- May 2, 1986
- Product Code
- GEX
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | FDA class 2 | General, Plastic Surgery |
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Other Clearances by ENDO LASE, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K853900 | ENDO-LASE CD40 FOR NEUROSURGERY | Jun 18, 1986 | Substantially Equivalent |
| K853903 | ENDO-LASE CD40 CO2 FOR GYNECOLOGY | Feb 21, 1986 | Substantially Equivalent |
| K853876 | ENDO-LSE CD-100 CO2 LASER FOR GYNECOLOGY | Feb 21, 1986 | Substantially Equivalent |
| K855093 | MEDILAS 2 ND:YAG LASER SURGERY SYSTEM | Feb 21, 1986 | Substantially Equivalent |
| K853901 | ENDO-LASE CD 40 FOR DERMATOLOGY | Feb 19, 1986 | Substantially Equivalent |
| K853877 | ENDO-LASE CD-100 CO2 LASER FOR DERMATOLOGY | Feb 19, 1986 | Substantially Equivalent |
| K853580 | MEDILAS 2 | Feb 13, 1986 | Substantially Equivalent |
| K860152 | MODEL 700 EVACUATOR FOR USE WITH LASER SURGERY | Feb 5, 1986 | Substantially Equivalent |
| K853875 | ENDO-LASE CD-100 CO2 LASER FOR OTORHINOLARYNGOLOGY | Jan 9, 1986 | Substantially Equivalent |
| K853902 | ENDO-LASE CD40 FOR OTORHINOLARYNGOLOGY | Jan 9, 1986 | Substantially Equivalent |